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  <title>Children's Benadryl 
 <sup>®</sup> DYE-FREE ALLERGY
</title>
  <effectiveTime value="20241127"/>
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        <name>Kenvue Brands LLC</name>
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                <name>Childrens Benadryl DYE-FREE ALLERGY</name>
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                <asEntityWithGeneric>
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                    <name>DIPHENHYDRAMINE HYDROCHLORIDE</name>
                    <activeMoiety>
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                        <name>DIPHENHYDRAMINE</name>
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                    <numerator unit="mL" value="118"/>
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                            <low value="20151201"/>
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                        <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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                    <originalText>Clear, colorless</originalText>
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              <consumedIn>
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          <text>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">Drug Facts</content>
              </content>
            </paragraph>
          </text>
          <effectiveTime value="20210729"/>
        </section>
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        <section>
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          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title>Active ingredient (in each 5 mL)</title>
          <text>
            <paragraph>Diphenhydramine HCl 12.5 mg</paragraph>
          </text>
          <effectiveTime value="20210729"/>
        </section>
      </component>
      <component>
        <section>
          <id root="dd9ef93d-99d8-d97d-e053-2a95a90acea3"/>
          <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
          <title>Purpose</title>
          <text>
            <paragraph>Antihistamine</paragraph>
          </text>
          <effectiveTime value="20210729"/>
        </section>
      </component>
      <component>
        <section>
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          <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
          <title>Uses</title>
          <text>
            <list listType="unordered" styleCode="Square">
              <item>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
        
  
   <list listType="unordered" styleCode="Square">
                  <item>runny nose</item>
                  <item>sneezing</item>
                  <item>itchy, watery eyes</item>
                  <item>itching of the nose or throat</item>
                </list>
              </item>
            </list>
          </text>
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          <title>Warnings</title>
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              <code code="50570-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - DO NOT USE SECTION"/>
              <text>
                <paragraph>
                  <content styleCode="bold">Do not use</content>
                </paragraph>
                <list listType="unordered" styleCode="Square">
                  <item>to make a child sleepy</item>
                  <item>with any other product containing diphenhydramine, even one used on skin</item>
                </list>
              </text>
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            </section>
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          <component>
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              <code code="50569-3" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR SECTION"/>
              <title>Ask a doctor before use if the child has</title>
              <text>
                <list listType="unordered" styleCode="Square">
                  <item>a breathing problem such as chronic bronchitis</item>
                  <item>glaucoma</item>
                </list>
              </text>
              <effectiveTime value="20210729"/>
            </section>
          </component>
          <component>
            <section>
              <id root="dd9ef93d-99dd-d97d-e053-2a95a90acea3"/>
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              <text>
                <paragraph>
                  <content styleCode="bold">Ask a doctor or pharmacist before use if the child is</content> taking sedatives or tranquilizers
        

 </paragraph>
              </text>
              <effectiveTime value="20210729"/>
            </section>
          </component>
          <component>
            <section>
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              <code code="50567-7" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - WHEN USING SECTION"/>
              <title>When using this product</title>
              <text>
                <list listType="unordered" styleCode="Square">
                  <item>marked drowsiness may occur</item>
                  <item>sedatives and tranquilizers may increase drowsiness</item>
                  <item>excitability may occur, especially in children</item>
                </list>
              </text>
              <effectiveTime value="20210729"/>
            </section>
          </component>
          <component>
            <section>
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              <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
              <text>
                <paragraph>
                  <content styleCode="bold">Keep out of reach of children.</content> In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
        

 </paragraph>
              </text>
              <effectiveTime value="20210729"/>
            </section>
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      <component>
        <section>
          <id root="dd9ef93d-99e0-d97d-e053-2a95a90acea3"/>
          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <title>Directions</title>
          <text>
            <list listType="unordered" styleCode="Square">
              <item>find right dose on chart below</item>
              <item>mL = milliliter</item>
              <item>take every 4 to 6 hours, or as directed by a doctor</item>
              <item>do not take more than 6 doses in 24 hours</item>
            </list>
            <table styleCode="Noautorules" width="70%">
              <col align="left" valign="top" width="50%"/>
              <col align="left" valign="top" width="50%"/>
              <thead>
                <tr styleCode="Toprule Botrule">
                  <th styleCode="Rrule">Age (yr)</th>
                  <th>Dose (mL)</th>
                </tr>
              </thead>
              <tbody>
                <tr styleCode="Botrule">
                  <td styleCode="Rrule">children under 2 years</td>
                  <td>do not use</td>
                </tr>
                <tr styleCode="Botrule">
                  <td styleCode="Rrule">children 2 to 5 years</td>
                  <td>do not use unless directed by a doctor</td>
                </tr>
                <tr>
                  <td styleCode="Rrule">children 6 to 11 years</td>
                  <td>5 mL to 10 mL</td>
                </tr>
              </tbody>
            </table>
            <paragraph>
              <content styleCode="bold">Attention:</content> use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
      

 </paragraph>
          </text>
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          <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
          <title>Other information</title>
          <text>
            <list listType="unordered" styleCode="Square">
              <item>
                <content styleCode="bold">each 5 mL contains:</content> sodium 10 mg
       
 
  </item>
              <item>store between 20-25°C (68-77°F)</item>
              <item>
                <content styleCode="bold">do not use if carton tape or bottle wrap imprinted with "Sealed For Your Safety" is broken or missing</content>
              </item>
              <item>see bottom panel for lot number and expiration date</item>
            </list>
          </text>
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          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>Inactive ingredients</title>
          <text>
            <paragraph>anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution</paragraph>
          </text>
          <effectiveTime value="20210729"/>
        </section>
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        <section>
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          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <title>Questions or comments?</title>
          <text>
            <paragraph>call 
       
 
  <content styleCode="bold">1-877-717-2824</content> or 
       
 
  <content styleCode="bold">215-273-8755</content> (collect)
      

 </paragraph>
          </text>
          <effectiveTime value="20210729"/>
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        <section>
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          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <title>PRINCIPAL DISPLAY PANEL</title>
          <text>
            <paragraph>NDC 50580-535-01</paragraph>
            <paragraph>Children's
       
 
  <br/>Benadryl
       
 
  <sup>®</sup>
            </paragraph>
            <paragraph>DYE-FREE ALLERGY</paragraph>
            <paragraph>Diphenhydramine HCl/antihistamine
       
 
  <br/>12.5 mg/5 mL oral solution
      

 </paragraph>
            <paragraph>4-6 Hours/Dose</paragraph>
            <paragraph>RELIEF OF:</paragraph>
            <list listType="unordered" styleCode="Disc">
              <item>Runny Nose
       </item>
              <item>Sneezing
       </item>
              <item>Itchy,Watery Eyes
       </item>
              <item>Itchy Throat or Nose
       </item>
            </list>
            <paragraph>✔ Free Of:</paragraph>
            <list listType="unordered" styleCode="Disc">
              <item>Dyes</item>
              <item>Alcohol</item>
              <item>Sugar</item>
              <item>Parabens</item>
              <item>High Fructose
        
  
   <br/>Corn Syrup
       
 
  </item>
            </list>
            <paragraph>Bubble Gum!
       
 
  <br/>Flavored Liquid
      

 </paragraph>
            <paragraph>4 fl oz (118 mL)</paragraph>
            <renderMultiMedia referencedObject="MM1"/>
          </text>
          <effectiveTime value="20210729"/>
          <component>
            <observationMedia ID="MM1">
              <text>Principal Display Panel</text>
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